ARTICLE | Clinical News

ALT drops alagebrium in hypertension

June 11, 2005 1:31 AM UTC

Alteon (ALT) discontinued the Phase IIb SPECTRA trial of alagebrium to treat hypertension and will no longer pursue the indication. An independent review committee determined the trial was unlikely to meet the primary endpoint of three-month reduction in systolic blood pressure.

ALT also said FDA placed a clinical hold on the Phase IIa EMERALD trial of alagebrium to treat erectile dysfunction (ED), and the company is awaiting the agency's decision about the Phase IIa PEDESTAL heart failure trial. ALT voluntarily halted all three trials in February after seeing liver alterations in rats (see BioCentury Extra, Thursday Feb. 24, 2005). Last month, ALT reported preliminary data from additional preclinical toxicology studies in rats showing that liver alterations are not caused by genotoxicity pathways, but may be a result of the male rat metabolism. ALT said the only patients still receiving alagebrium are a few patients in PEDESTAL. ...